WiGeV Klinik Ottakring
Vienna, State of Vienna, 1160, Austria
Location status: Recruiting
NCT Number: NCT07138326
Peroral administration is the preferred way of taking medication. However, the special absorption conditions in ostomy patients are generally not addressed in approval studies and there is also little other literature on this topic. These are usually case reports or studies on individual patients or very small patient collectives.
For medications with measurable clinical parameters, e.g. blood pressure, blood sugar, etc: Blood pressure, blood sugar, etc., these can be used to draw conclusions about any absorption problems. For medications without the possibility of a direct and objective assessment, the assessment is difficult due to the very low level of evidence. Drug groups without a direct physiological measure are e.g: Psy-chotropic drugs (antipsychotics, antidepressants, anxiolytics) and also the novel oral anticoagulants (NOACs).
The clinical trial´s results will answer the following questions:
* Are therapeutic blood levels of psychotropic drugs and NOACs achieved in ostomy patients when taken orally in the usual way? * Are there differences between the measured levels of ileostomy and colostomy patients? Colostomy and ileostomy patients undergoing inpatient or outpatient treatment at the Klinik Ottakring are ready for inclusion. The blood samples will be obtained during medically indicated and performed blood draws within the scope of medical practice, so that no study-associated risks arise here.
Recorded and evaluated:
* Relevant patient data * Plasma levels of the drugs under investigation in ostomy patients. The therapeutic range specified in the respective approval studies serves as the reference value. The results obtained are documented, evaluated and interpreted in an appropriate manner.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Vienna, State of Vienna, 1160, Austria
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Planned inclusion criteria:
Exclusion criteria
Insurmountable language barrier
Monitoring
Time frame: 18 month
During a routine blood draw, an additional 2ml (Psychotropic drugs: citalopram, clozapine, duloxetine, escitalopram, melperone, mianserin, milnacipran, mirtazapine, olanzapine, paliperidone, paroxetine, pregabalin, prothipendyl, quetiapine, risperidone, sertraline, trazodone, venlafaxine)or 3.5 ml (NOACs: edoxaban, rivaroxban, apixaban)of blood is taken. In this sample, the drug levels are determined using a validated method ( LC-MS/MS (Psychotropic drugs) or chromogenic test (NOACs)). The drug level [µg/ml] determined in this way is compared with the therapeutic target range specified in the respective approval studies.
Contact information is provided by the study sponsor or research team.
Irene Lagoja, Dr
CONTACT
Stefanie Hehenberger, Mag
CONTACT
WiGeV Klinik Ottakring
Other
Beeinflussung Der Resorption Von Arzneimitteln Bei Stoma Patient*Innen
Acronym: STAR
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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